2-butylaminoethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(only 50 µL of the test substance were used and the observation period was 8 days)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butylethanolamine

IUPAC Name:

Butylethanolamine

Details on test material:

- Name of test material (as cited in study report): Butylethanolamine
- Analytical purity: >99%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.19 and 3.17 kg
- Diet: Sniff (no further details were given)
No further data.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The adjacent eye served as saline control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

1.5

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

0

Reversibility:

other: not affected

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 13

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 15

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Results 16

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Any other information on results incl. tables

Findings: animal 1 / animal 2

Time	corneal opacity	erythema	chemosis	iritis
1 h	2/3	0/2	2/1	0/0
24 h	2/3	2/2	2/2	0/0
48 h	2/3	2/2	1/2	2/0
72 h	-/-	-/-	-/-	-/-
8 d	3/3	2/2	2/2	2/0
mean	2/3	2/2	1.5/2	1/0

Mean values over 24 and 48 h. Effects were not evaluated after 72 h

The substance led to bloody secretion 1 h after application in both animals. Detachment of the cornea was observed in one animal 48 h after application. At the end of the observation period after 8 days necrosis of the eyelids, loss of hair around the eye, corrosion and purulence was observed.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Butylethanolamine produced serious damage to rabbits' eyes.

Executive summary:

In a primary eye irritation study (BASF 1977) 0.05 mL of the unchanged test substance was instilled into the conjunctival sac of two Vienna White rabbits (without washing). Animals then were observed for 8 days. The original grading was converted into the numerical grading according to Draize. The test substance led to bloody secretion 1 h after application in both animals. Detachment of the cornea was observed in one animal 48 h after application. The mean (24 – 48 h) cornea, conjunctivae, chemosis and iris score was 2, 2, 1.5, 1 for animal 1 and 3, 2, 2, 0 for animal 2, respectively. All effects were not reversible within 8 days. Additionally, necrosis of the eyelids, loss of hair around the eye, corrosion and purulence was observed at the end of the observation period after 8 days.